Evaluation of Zinc and / or Micronutrient Supplementation on Intestinal Flora, Diarrheal Disease Burden, Intestinal Mucosal Integrity and Growth Among Children of Pakistan

Phase 2

Completed

• Conditions: Malnutrition; Diarrhea; Pneumonia; Growth
• Interventions: Other: Nutritional Counselling and Education; Dietary Supplement: Micronutrient Supplementation without Zinc; Dietary Supplement: Micronutrient Supplementation with Zinc

• Registration Number: NCT00705445
• Lead Sponsor: Aga Khan University

Brief Summary

Information on the mechanisms of zinc is still in developing phase. Ecological and biological implications of long term zinc supplementation at population level requires assessment. The trial aims to assess the impact of routine supplementation of zinc among young growing children and evaluate its impact on intestinal microbial flora and relationship with gut mucosa integrity and co-morbidities.

Detailed Description

WHO has recommended the use of zinc for the treatment of acute diarrhea. Literature supports up-scaling of zinc supplementation programs to prevent childhood illnesses, such as diarrhea and respiratory infections, and its subsequent co-morbid conditions. As the potential mechanisms of action of zinc still remains to be established, this trial is proposed to evaluate the relationship of intestinal microbial flora, intestinal permeability, morbidity patterns and response to various enteric pathogens in a representative birth cohort randomly allocated to receive daily zinc and micronutrients from 6-18 months of age, and a control population.

Study Timeline

• Study First Submitted: 2008-06-25
• Study First Submitted QC: 2008-06-25
• Study First Posted: 2008-06-26
• Study Start: 2008-11
• Primary Completion: 2011-06
• Study Completion: 2012-07
• Status Verified: 2012-08
• Last Update Submitted: 2012-08-27
• Last Update Posted: 2012-08-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2745

Inclusion Criteria

• Children of ages 2 weeks to 6 months for recruitment into the Trial. Children of ages 6 months and onwards would eligible to receive intervention (in the form of Micronutrient Sprinkles)

Exclusion Criteria

• Children with obvious congenital anomalies.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	Nutritional Counselling and Education	This group will not receive any of the intervention supplements. The group will only receive nutritional counselling and education, and treatment provided for any encountered illness according to IMCI guidelines.
B	Micronutrient Supplementation without Zinc	This group will receive micronutrient supplements containing microencapsulated Iron, Vitamin C, Vitamin A, Vitamin D, and Folic Acid. This group will also receive Nutritional Counselling and Education and treatment according to IMCI Guidelines for any serious illness.
C	Micronutrient Supplementation with Zinc	This group will receive Micronutrient Supplements containing Microencapsulated Iron, Vitamin C, Vitamin A, Vitamin D, Folic Acid, and Zinc. This group will also receive nutritional counselling, education and treatment according to IMCI Guidelines in case of any untoward illness.

Primary Outcome Measures

Name	Time	Method
Episodes of Diarrhea and additional morbidity such as acute lower respiratory tract infection, pneumonia and days with severe illness.	2 years

Trial Locations

Locations (2)

The Aga Khan University; 🇵🇰 Karachi, Sindh, Pakistan

Project Office, Matiari; 🇵🇰 Matiari, Sindh, Pakistan